A dose-saving method to stretch vaccine supplies was approved by the U.S. government on Tuesday in the face of a severe vaccine shortage.
Jynneos, the only vaccine licensed against monkeypox in the U.S., was granted an emergency use authorization by the Food and Drug Administration on Tuesday.
As there is a high concentration of immune cells just under the skin, lower doses of vaccine can be used to elicit a similar response to other methods.
The method is supported by clinical studies and will not compromise standards, but the data supporting the strategy is limited, according to the officials.
A substantial amount of training will be needed to ensure shots are given correctly because few medical practitioners actually have experience.
The swelling, redness, and itching associated with the shots could pose a challenge to vaccine take up, as they appear to produce more swelling, redness, and itching compared to standard dose.
He said that this is not likely to deter men who have sex with men from doing so.
The FDA allowed the Jynneos monkeypox vaccine to be given by injection. The method quintuples the number of doses available in the national stockpile by using one-fifth of the dose. The spread of the virus in recent weeks made it clear that the current vaccine supply wouldn't meet demand. The Health and Human Services Secretary said in a statement that the new strategy will give more people the opportunity to get vaccine while maintaining high standards.
The vaccine for monkeypox performs well in practice. Data on the real-world use of monkeypox vaccines is very limited, and the effectiveness of any strategies against monkeypox in humans is unknown and untested. This lack of research is largely due to the rarity of the disease before the current outbreak, but these were largely ignored by the rest of the world. The small study cited by the FDA supports the use of the vaccine in a way that protects against the disease. The most important thing is to conduct rigorous clinical trials as soon as possible to determine whether this is the best approach or not.
He thinks the new approach is the best one. The desire for more data has to be weighed against the seriousness of the situation as we do not have great data about the level of protection from either vaccine
The only vaccine approved for use against monkeypox in the world is Imvanune in Canada. It is very rare and in short supply. Jynneos is better due to the special training required to administer other vaccines and the risk of potentially dangerous side effects. The vaccine shortage in the U.S. has been caused by a number of errors, including delays in ordering the vaccine and a failure to replace expired vaccine. Many local governments decided to delay giving the second dose of the vaccine in order to give more people access to the first shot.
A total of 9,487. According to the Centers for Disease Control and Prevention, there has been at least one confirmed case of monkeypox or orthopoxviruses in the U.S. The total number of confirmed cases is 31,800. Evidence points to sexual contact as a key driver of transmission for gay, bisexual and men who have sex with men. Monkeypox is usually spread through close contact.
The Biden administration has authorized a vaccine dose strategy to stretch supplies.
The US could have had more Monkeypox vaccine this year.
There is a one-dose monkeypox vaccine strategy that could help extend supplies.